Hydroxychloroquine...........

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Palovic
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9:31a, 3/19/20
That statement is extremely misrepresentative of what is occurring in Italy. While they have started utilizing Chloroquine (not in vast amounts from any report I have read as they are still testing all options in the field), the issue is that most patients are coming to them having to be intibated day one just to get enough oxygen. They do not have enough resources to intibate all patients to allow the treatments time to work even if they are effective and a majority of the cases have co-existing conditions and are causing a majority of the challenges. There are cases of individuals that have no co-existing conditions and elderly needing bentallation and there are no resources and they become critically ill quickly due to lack of oxygen all due to the high volume of challenging cases.

Lets be sure to not be so dismissive of all data points during times like this as most breakthroughs start by this same process of testing in small groups.

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Dr. Not Yet Dr. Ag
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In reply to Palovic • 9:38a, 3/19/20
Palovic said:
That statement is extremely misrepresentative of what is occurring in Italy. While they have started utilizing Chloroquine (not in vast amounts from any report I have reaf as they are still testing all options in the field), the issue is that most patients are coming to them having to be intibated day one just to get enough oxygen. They do not have enough resources to intibate all patients to allow the treatments time to work even if they are effective and a majority of the cases have co-existing conditions and are causing a majority of the challenges. There are cases of individuals that have no co-existing conditions and elderly needing bentallation and there are no resources and they become critically ill quickly due to lack of oxygen all due to the high volume of challenging cases.

Lets be sure to not be so dismissive of all data points during times like this as most breakthroughs start by this same process of testing in small groups.


And the same can be said about the misrepresentation of what's going on in South Korea in the comment I responded to. Let's ignore early testing, early quarantine, a healthier and younger population, and a much greater denominator due to expansive testing and claim HCQ therapy is solely responsible for SK's better looking numbers.

My point is that all drugs need to go through the appropriate vetting process prior to rapid, widespread use. Such blind utilization can have untoward complications like drug shortages for indications where it is clinically proven to help (like SLE and RA).

Have hope but be wary.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
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SMM48
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In reply to Ag_of_08 • 10:11a, 3/19/20
AG
I saw 46.....but I'll go with ya......it's been around awhile
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Schall 02
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10:44a, 3/19/20
AG
POTUS talking about this drug right now.
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TxAgLaw03RW
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In reply to Schall 02 • 10:48a, 3/19/20
AG
Is he saying it's now FDA approved for COVID? Huge news I think
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jeffdjohnson
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In reply to TxAgLaw03RW • 10:50a, 3/19/20
Wozlaw said:
Is he saying it's now FDA approved for COVID? Huge news I think
Yes. They don't want to promise anything but they wouldn't let Trump announce it unless they felt positive about it.
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TxAgLaw03RW
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In reply to jeffdjohnson • 10:51a, 3/19/20
AG
Agreed. I hope the FDA head and others weigh in the explain in more detail.
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JD Shellnut
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10:54a, 3/19/20
AG
Will this drug help people with co morbitities too, or just "healthy" patients with the virus?
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Yukon Cornelius
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In reply to TxAgLaw03RW • 11:01a, 3/19/20
AG
Wozlaw said:
Agreed. I hope the FDA head and others weigh in the explain in more detail.
hes doing that right now if you turn on the presser.
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FTAG 2000
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In reply to Dr. Not Yet Dr. Ag • 11:05a, 3/19/20
AG
Dr. Not Yet Dr. Ag said:
Italy has been using it as well, hows that going for them? This is how science works. You need to prove a medication is actually effective.

South Korea, Japan, France, Australia, all using it successfully.

Lots of the Italy cases are coming in and going straight to ICU. Just from appearances Italy patients seem to be farther along before they are able to get treatment.

There are far more positive data points than negative. Hope the view is nice up there on that hill you seem intent on dying on.
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TxAgLaw03RW
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In reply to Yukon Cornelius • 11:07a, 3/19/20
AG
Listening. I imagine they'll discuss in the Q&A what this means for us now, or if this doesn't change anything near term with our inability to live normally.
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Palovic
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11:09a, 3/19/20
Drifter. This drug helps everyone but I think your question is structured incorrectly. It will not cure the co-exisitng conditions but what it does it effectively allows other drugs and or supplements like zinc to effectively stop viral reproduction process of the RNA virus.

Timing is everything in this treatment as there are studies that show that this treatment can remove all signs of the virus in a fast as 6 days but most people are currently waiting until they are having issues with respitory inflammation and then have to be intibated while the treatment is then given. The challenge in Italy is that most people cannot go 6-10 days without ventilators for this treatment.

I think the correct approach may be that they prescribe at the onset of the symptoms and diagnosis and not wait.

Just my opinion
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Big Baccala
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In reply to Marcus Aurelius • 11:12a, 3/19/20
AG
Marcus Aurelius said:
It's on shelves. It will diminish. Why I pray Trump orders military re-tooling of big Pharma to make hydrochloroquine and redesimivir.
Regarding Hydroxychloroquine: Don't need big pharma. There are plenty of generic companies with FDA approval to make and sell. No retooling needed, as long as the API is available. It is an immediate release formulation so it is a blend and compress process to make the tablets. Modern double-sided high speed tablet presses run at rates in excess of 150k per hour. The facility that I ran had 3 of these presses plus several other presses with a total capacity to make 70 million tablets/month. Bottom line if it works availability should not be a problem.
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Schall 02
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11:14a, 3/19/20
AG
Can I just say that I F' ING LOVE TEXAGS and my fellow Ags.

WHOOOOP!
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Dr. Not Yet Dr. Ag
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In reply to FTAG 2000 • 11:20a, 3/19/20
AG 2000' said:
Dr. Not Yet Dr. Ag said:
Italy has been using it as well, hows that going for them? This is how science works. You need to prove a medication is actually effective.

South Korea, Japan, France, Australia, all using it successfully.

Lots of the Italy cases are coming in and going straight to ICU. Just from appearances Italy patients seem to be farther along before they are able to get treatment.

There are far more positive data points than negative. Hope the view is nice up there on that hill you seem intent on dying on.

They are all using it, period. We can not determine its efficacy without RCTs or strongly indicative, well controlled observational data. This isn't some sort of extreme opinion, this is how medicine works. There are no data points yet. Anecdotes are not data. Pointing to entire country's CFR as data is laughable given the absurd amount of confounding variables.

Is it possible HCQ works? Absolutely, but appropriate science and medication use should not abandoned because people are scared or are desperate for a cure. The history of medicine if rife with unfortunate, unintended consequences. A recent example of this is Xigris for sepsis care, and there was plenty of "positive data points" prior to that being pulled from the market.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
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cone
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In reply to JD Shellnut • 11:20a, 3/19/20
AG
i think it's more for the healthier patients to get them up and out

asian countries have been using the cocktail as well

i don't think it's a full spectrum treatment
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Hey Nav
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12:09p, 3/19/20
AG
Is Hydroxychloroquine similar to an old drug called mefloquine (brand name Larium) ?

Just coincidentally, the latest issue of DAV Magazine discusses mefloquine use by the DOD from 1989 to 2009, when DOD "issued directives effectively making it a last-choice drug for troops".

https://www.dav.org/wp-content/uploads/Magazine_2020_MarApr.pdf

The article starts on p18.

Sounds like this anti-malaria drug messed up a lot of people.
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California Ag 90
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12:13p, 3/19/20
AG
great thread.

one of you biochemists who understands this stuff - it would be interesting how/why azithromycin would chemically enhance efficacy of hydrochloroquine.

just very curious about how that would work if there's any theories.

We're from North California, and South Alabam
and little towns all around this land...
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94chem
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12:20p, 3/19/20
Could be an "accidental" outbreak at Leavenworth soon to allow accelerated testing.
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Buck Compton
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In reply to California Ag 90 • 12:22p, 3/19/20
AG
California Ag 90 said:
great thread.

one of you biochemists who understands this stuff - it would be interesting how/why azithromycin would chemically enhance efficacy of hydrochloroquine.

just very curious about how that would work if there's any theories.

Based on what I've read, the Z-Pack just helps clear up any secondary bacterial infections (such as a bacterial pneumonia). May have limited antiviral properties, but it is primarily to allow the body to focus on the virus.

But I am certainly no biochemist.
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Pelayo
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In reply to Dr. Not Yet Dr. Ag • 12:28p, 3/19/20
AG
Dr. Not Yet Dr. Ag said:
AG 2000' said:
Dr. Not Yet Dr. Ag said:
Italy has been using it as well, hows that going for them? This is how science works. You need to prove a medication is actually effective.

South Korea, Japan, France, Australia, all using it successfully.

Lots of the Italy cases are coming in and going straight to ICU. Just from appearances Italy patients seem to be farther along before they are able to get treatment.

There are far more positive data points than negative. Hope the view is nice up there on that hill you seem intent on dying on.

They are all using it, period. We can not determine its efficacy without RCTs or strongly indicative, well controlled observational data. This isn't some sort of extreme opinion, this is how medicine works. There are no data points yet. Anecdotes are not data. Pointing to entire country's CFR as data is laughable given the absurd amount of confounding variables.
I will beg to differ,,,,some. When you have a novel crises of this scale and the goal is to prevent critical cases from overwhelming the system, you go with what you have. Waiting for double blinded RCT is not always reasonable when the treatment is pretty benign and there is evidence, even case series, that suggest a benefit. It is a judgement call based on what we know, and prior experience with the drug.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
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FTAG 2000
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In reply to Dr. Not Yet Dr. Ag • 12:45p, 3/19/20
AG
Dr. Not Yet Dr. Ag said:
AG 2000' said:
Dr. Not Yet Dr. Ag said:
Italy has been using it as well, hows that going for them? This is how science works. You need to prove a medication is actually effective.

South Korea, Japan, France, Australia, all using it successfully.

Lots of the Italy cases are coming in and going straight to ICU. Just from appearances Italy patients seem to be farther along before they are able to get treatment.

There are far more positive data points than negative. Hope the view is nice up there on that hill you seem intent on dying on.

They are all using it, period. We can not determine its efficacy without RCTs or strongly indicative, well controlled observational data. This isn't some sort of extreme opinion, this is how medicine works. There are no data points yet. Anecdotes are not data. Pointing to entire country's CFR as data is laughable given the absurd amount of confounding variables.

Is it possible HCQ works? Absolutely, but appropriate science and medication use should not abandoned because people are scared or are desperate for a cure. The history of medicine if rife with unfortunate, unintended consequences. A recent example of this is Xigris for sepsis care, and there was plenty of "positive data points" prior to that being pulled from the market.

Is that how medicine and science works? Thanks, had no idea.

Hopefully somewhere in your remaining studies to become a doctor there's a course on not coming across as a condescending know it all to others.
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74Ag1
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1:03p, 3/19/20
AG
Approved
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Dr. Not Yet Dr. Ag
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In reply to Pelayo • 1:03p, 3/19/20
Pelayo said:
Dr. Not Yet Dr. Ag said:
AG 2000' said:
Dr. Not Yet Dr. Ag said:
Italy has been using it as well, hows that going for them? This is how science works. You need to prove a medication is actually effective.

South Korea, Japan, France, Australia, all using it successfully.

Lots of the Italy cases are coming in and going straight to ICU. Just from appearances Italy patients seem to be farther along before they are able to get treatment.

There are far more positive data points than negative. Hope the view is nice up there on that hill you seem intent on dying on.

They are all using it, period. We can not determine its efficacy without RCTs or strongly indicative, well controlled observational data. This isn't some sort of extreme opinion, this is how medicine works. There are no data points yet. Anecdotes are not data. Pointing to entire country's CFR as data is laughable given the absurd amount of confounding variables.
I will beg to differ,,,,some. When you have a novel crises of this scale and the goal is to prevent critical cases from overwhelming the system, you go with what you have. Waiting for double blinded RCT is not always reasonable when the treatment is pretty benign and there is evidence, even case series, that suggest a benefit. It is a judgement call based on what we know, and prior experience with the drug.


Agree to disagree, linked below is the NEJM RCT on Lopinavir/Ritonavir (meds that have also been frequently utilized against CoVID) which was literally just published. This isn't like toxicology literature where cases are so rare that it is impossible to perform an RCT. I'm all for expedited peer review process in situations like this which is what is currently happening. I assume we will likely get a HCQ RCT soon, as I'm sure China probably studied most of the meds we are currently using. I am also all for compassionate use of meds in severe cases, I'm just not ready to start rx'ing this to mild or asymptomatic cases until we have reliable data that it is effective. Doing so would likely lead to national shortages of the med.

https://www.nejm.org/doi/full/10.1056/NEJMoa2001282?query=TOC
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cone
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In reply to Dr. Not Yet Dr. Ag • 1:07p, 3/19/20
AG
word on the street is that this hcq cocktail works better to prevent more acute mild cases from getting worse

but doesn't help as much as the severity increases
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Palovic
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1:16p, 3/19/20
Cone. Good points but I think the fight changes completely once you get into the Cytokine Storm. Chloroquine will continue to effectively treat the viral replication but you then have a slew of other issues that you are combating. That is why in my earlier post I mentioned timing is everything in the treatment and waiting for it to progress may not be the best course of action and unilateral treatment practices at onset of symptoms and confirmation of virus through testing.

Again, just my opinion.
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1208HawkTree
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In reply to Big Baccala • 1:33p, 3/19/20
AG
pbrancazio said:
Marcus Aurelius said:
It's on shelves. It will diminish. Why I pray Trump orders military re-tooling of big Pharma to make hydrochloroquine and redesimivir.
Regarding Hydroxychloroquine: Don't need big pharma. There are plenty of generic companies with FDA approval to make and sell. No retooling needed, as long as the API is available. It is an immediate release formulation so it is a blend and compress process to make the tablets. Modern double-sided high speed tablet presses run at rates in excess of 150k per hour. The facility that I ran had 3 of these presses plus several other presses with a total capacity to make 700 million tablets/month. Bottom line if it works availability should not be a problem.


My wholesaler is out of all mfg, brand or generic. Already had Rxs called in today by out of town docs for their family members, 20 days of Plaquenil each and two Zpaks...
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Big Baccala
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In reply to 1208HawkTree • 1:46p, 3/19/20
AG
1208HawkTree said:
pbrancazio said:
Marcus Aurelius said:
It's on shelves. It will diminish. Why I pray Trump orders military re-tooling of big Pharma to make hydrochloroquine and redesimivir.
Regarding Hydroxychloroquine: Don't need big pharma. There are plenty of generic companies with FDA approval to make and sell. No retooling needed, as long as the API is available. It is an immediate release formulation so it is a blend and compress process to make the tablets. Modern double-sided high speed tablet presses run at rates in excess of 150k per hour. The facility that I ran had 3 of these presses plus several other presses with a total capacity to make 700 million tablets/month. Bottom line if it works availability should not be a problem.


My wholesaler is out of all mfg, brand or generic. Already had Rxs called in today by out of town docs for family members, 20 days of Plaquenil each and two Zpaks...
News on this drug has been out for a couple of weeks so I would assume supply is gone. If API is available at the manufacturing sites, I would expect a 3-4 week lead time from start of manufacturing to shipment into the supply chain. I hope your family members are fortunate enough to have only mild cases of this virus and do not need this treatment.
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1208HawkTree
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1:50p, 3/19/20
AG
Not MY family, members of the doc's family.
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ttuhscaggie
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In reply to Dr. Not Yet Dr. Ag • 1:57p, 3/19/20
AG
The side effect profile for Plaquenil is minimal. It's been widely used for years and never pulled from the market. The same old rules do not apply during a pandemic. But by all means, if you get sick you should feel free to decline treatment until further studies are peer reviewed and stage 3 clinical trials completed. Lol
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Dr. Not Yet Dr. Ag
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In reply to ttuhscaggie • 2:09p, 3/19/20
The side effect profile is not what I'm worried about. See the comments above you.
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Marcus Aurelius
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2:44p, 3/19/20
AG
Agree with other doc comments re this. During a pandemic which threatens a significant percentage of the planet and and is having devastating effects on the world economy, an "ivory tower" academic assessment of potential therapy is unrealistic and frankly dangerous. Especially given the fact that HCQ is a relatively benign drug. There is no time for a large RPCT. There is enough retrospective data to suggest its efficacy against COVID-19. Hence the administration is fast tracking its approval.
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Blackstreet
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In reply to Dr. Not Yet Dr. Ag • 4:18p, 3/19/20
AG
No offense but I'm assuming you do not practice medicine in the "real world". I'm also assuming you may still be in school or residency training. There is an art and science in medicine that goes far beyond RCT's and academia. You obviously haven't learned the latter yet. Step down a second and quit " "challenging" those who have done this for years and know how medicine really and should work.
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Dr. Not Yet Dr. Ag
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In reply to Blackstreet • 4:47p, 3/19/20
Board certified, non academic that has been out of residency for several years. I don't care about its use for severe disease, I think that is perfectly appropriate, my issue is widespread use for mild disease. HCQ is now on national shortage as of today. The reason why? People promoting this as a potential cure when we don't have evidence to claim that. Nearly all of the nearby pharmacies in my area are out currently. Now all our RA and SLE patients get to suffer.
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Blackstreet
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5:22p, 3/19/20
AG
My response was not to this, it was to the need to have RCT to apply the medicine towards COVID as we are doing. I'm surprised someone "with your experience" would think this way in this specific situation. To each his own. It's very unfortunate that there is a shortage TODAY. Hopefully, the manufactures can ramp up production and those with chronic conditions can stay on their therapy or have minimal breaks in therapy. There are alternative therapies for them potentially at least. As of now, there really isn't any alternative for those dealing with COVID with the information we currently have. We deal with recalls, shortages, insurance denials, daily. Again, real world medicine. As you and I know, the shortage is most likely due to precautionary prescriptions to those who want it just in case. I refuse to do that. I think of it like Tamiflu, to shorten the duration and prevent complications. How do you know that the mild will not be severe with this thing? I just disagree with this approach. Again, "the art of medicine". Good luck with your patients and I hope we all do well.
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